European Commission Grants Orphan Medicinal Product Designation to Nektar's Amphotericin B Inhalation Powder (ABIP) for the Prevention of Pulmonary Fungal Infections in Patients Deemed At Risk



    Nektar Therapeutics (Nasdaq:NKTR) announced today that
    its Amphotericin B Inhalation Powder (ABIP) product has been granted
    orphan medicinal product designation by the European Commission for
    the prevention of pulmonary fungal infections in patients deemed at
    risk. This designation is based on a recommendation from the Committee
    for Orphan Medicinal Products (COMP) of the European Medicines Agency
    (EMEA).
    "Prevention of these serious fungal infections in the lung is a
    major priority, given the increasing incidence of invasive pulmonary
    aspergillosis in immunosuppressed patients," said Dr. David Denning,
    professor of medicine and medical mycology at the University of
    Manchester. "Any therapy that reduces the incidence of invasive
    pulmonary aspergillosis in particular is welcome, as these infections
    are frequently fatal, and can be expensive to treat."
    According to the EMEA, orphan medicinal products are for
    diagnosing, preventing or treating life-threatening or very serious
    conditions that are rare and affect less than five of every 10,000
    persons in the European Union (EU). An orphan drug designation
    provides 10 years of potential market exclusivity if the product
    candidate is approved for marketing in the EU. It also allows for
    regulatory assistance in preparing the marketing application, free
    protocol assistance to optimize clinical development, reduced
    regulatory fees associated with applying for marketing approval and
    direct access to the centralized procedure for Marketing Authorization
    Application through the EMEA.
    "We are pleased to make continued progress in our ABIP program and
    look forward to using the scientific guidance and assistance available
    through the EMEA's Orphan Medicinal Drug Program," said David
    Johnston, Nektar senior vice president of research and development.
    "ABIP holds the promise of preventing fatal fungal infections that
    start in the lungs, can be very difficult to treat, and are associated
    with extremely high mortality rates in spite of currently available
    treatments."
    In the U.S., the Food and Drug Administration (FDA) granted both
    Fast Track designation and Orphan Drug designation to ABIP for
    prevention of pulmonary fungal infections in patients at risk for
    aspergillosis due to immunosuppressive therapy.

    About Amphotericin B Inhalation Powder (ABIP)

    ABIP is under development for the prevention of pulmonary fungal
    infections such as aspergillosis in high-risk immunosuppressed
    patients. The product is designed to target the site of infection
    directly with a novel formulation of amphotericin B, a broad spectrum,
    fungicidal drug. Nektar's innovative formulation and pulmonary
    delivery method could potentially eliminate systemic, dose-limiting
    toxicities found with current formulations of amphotericin B that are
    delivered intravenously.
    Immunosuppressed patients, for example, those receiving organ or
    stem cell transplants, or chemotherapy or radiation therapy for
    hematologic malignancies -- are vulnerable to opportunistic fungal
    infections, such as aspergillosis, which start in the lungs and spread
    throughout the body. Aspergillosis has a mortality rate of over 50%,
    and in some immunosuppressed patient groups the mortality rate may be
    near 100%.(1) Using ABIP for patients at risk of developing the
    infection may potentially reduce the incidence of these infections, as
    well as associated high morbidity and mortality and significant
    treatment costs.
    ABIP recently completed a multi-dose, dose escalation clinical
    study in preparation for pivotal trials to begin in 2007.

    (1) Lin et al. 2001, Aspergillosis Case-Fatality Rate: Systematic
    Review of the Literature. Clinical Infectious Disease, 32: 358-366.

    NOTE TO EDITORS: Information on ABIP data presented at major
    congresses by Nektar scientists is available by contacting Nektar
    Corporate Communications at 650-631-4954.

    About Nektar

    Nektar Therapeutics is a biopharmaceutical company that develops
    and enables differentiated therapeutics with its industry-leading drug
    delivery technologies, expertise and manufacturing capabilities.
    Nektar technology and know-how have enabled nine approved products for
    partners, which include the world's leading pharmaceutical and
    biotechnology companies. Nektar also develops its own products by
    applying its drug delivery technologies and expertise to existing
    medicines to enhance performance, such as improving efficacy, safety
    and compliance.

    This release contains forward-looking statements that reflect
    management's current views as to Nektar's clinical plans and
    expectations for a product under development, the potential for new
    product efficacy, safety, compliance, and economic benefits for
    patients, and the value and benefits of Nektar technologies such as
    ABIP. These forward-looking statements involve substantial risks and
    uncertainties including, without limitation, the uncertainty and
    expense of the clinical trial programs and uncertain regulatory
    approval process for new products (including those granted Orphan
    Medicinal Product Designation designation by EMEA) and the commercial
    feasibility of early stage development products such as ABIP. A
    further description of other important risks and uncertainties related
    to these forward-looking statements are detailed in Nektar's reports
    and other filings with the SEC, including its Annual Report on Form
    10-K for the year ended December 2005 and its Quarterly Report on 10-Q
    for the quarter ended March 31, 2006. Actual results could differ
    materially from these forward-looking statements. Nektar assumes no
    obligation to update any forward-looking statements contained in this
    release as the result of new information or future events or
    developments that may occur after the date of this release.